1. Technical Field
This invention concerns a software architecture for an integrated clinical laboratory system, and more particularly for automatically performing pre-analytical, analytical and post-analytical processing associated with laboratory testing.
2. Description of the Related Art
Testing of laboratory specimens is an important and integral part of the health care system and hospital operations. The results of such tests are often of critical importance in determining patient care and must therefore be provided reliably and efficiently at all times. However, in contemporary hospitals and independent analytical laboratories, the volume and variety of testing to be performed present a continual challenge to find more reliable and efficient means for managing, carrying out and reporting such tests.
Cost is also a factor which must be considered in the present health care environment. Hospitals and clinical labs are under increasing pressure to provide more and better results with less money. Accordingly, in order to survive, they must continue to find new and better ways to provide high quality care and testing at a reasonable price. One important cost factor associated with analytical testing can be attributed to the number of individuals required to maintain, operate and manage a clinical laboratory. Numerous individuals are needed for all manner of activities relating to the pre-analytical process, the analytical process, and the post-analytical process. For example, the pre-analytical process has typically included order entry, specimen collection and labeling, specimen receipt, specimen sorting, aliquoting, specimen delivery, work load balancing, and ordering reflex testing. The analytical process has traditionally included quality control analysis, analyzer checks, specimen identification, sample analysis, sample preparation and test repeats. Finally, the post-analytical process includes test data review, result verification, quality assurance analysis; insurance claims, result data storage, specimen storage, and specimen retrieval.
In order to reduce costs, various automated systems have been developed to assist in one or more of the process steps which are outlined above. However, such systems have typically been limited to processing exclusively associated with either the pre-analytical process, the analytical process, or the post-analytical process. In some cases communication interfaces have been provided to permit systems in one process area to communicate with systems in other process areas. However, such systems nevertheless fail to provide a comprehensive architecture which facilitates a truly integrated framework which is easily scalable in features, functions, and process areas.
For example, U.S. Pat. No. 5,614,415 to Markin discloses a method for automating a portion of the analytical process. In Markin, a doctor can request a test by entering data into a generalized hospital information computer system (HIS). This information is forwarded by the HIS to a separate laboratory information system (LIS). The LIS then assigns a technician to retrieve a specimen and provides a container having an identification code. The identification code can be cataloged at a receiving station. Information regarding the specimen and test to be performed is retrieved from the LIS and is subsequently used to automate various aspects of specimen transport. The system uses the LIS information for routing the specimen by conveyor to workstations where a required test is to be performed, prioritizing specimens for testing, and transmitting test results entered via a keyboard at the workstation to the LIS. The LIS may then communicate with the HIS or to the doctor by a separate workstation.
Another such system is disclosed in U.S. Pat. No. 5,631,844 to Margrey et al. The system includes a plurality of remote analyzing instruments, located for example at outpatient clinics. The plurality of analytical instruments at remote locations each interfaces with a dedicated computer having a local display to activate and interact with the analytical instrument. The computer also serves as an interface between the analytical instrument and a server. The server is for storing databases, including patient demographics and analysis results and for permitting automatic retrieval and storage of data on an interactive basis to a variety of users. A central laboratory with another computer and display interacts with the dedicated computers through the server to review, evaluate and accept or reject specimen analysis.
European Patent No. EP 0 676 053-B1 (WO94/15219) is related to U.S. Pat. No. 5,614,415 and discloses a method for automatically testing and tracking a specimen in a laboratory. The system utilizes a conveyor to move specimens to and from work locations. Each specimen and its carrier are marked with a machine readable code. Information is added to a computer database relative to each specimen, including the information as to the tests to be performed on each specimen, its machine readable code, as well as priority information. The specimens are moved by the conveyor to each work station where tests are performed and data concerning the test results is inputted to the computer database.
A major disadvantage of each of the prior art systems described above is that they fail to provide a comprehensive software architecture solution which is scalable for implementing some or all of the comprehensive collection of tasks associated with laboratory testing. These disadvantages are attributable, at least in part to the conventional view of a clinical laboratory work flow which has evolved over time. In particular, such systems have conventionally separated out processing associated with the pre-analytical, analytical, and post-analytical tasks described above. In compliance with this traditional view, conventional clinical laboratory systems have primarily been designed as independent and/or autonomous systems. This view obstructs the use of new computing technologies and is an obstacle to the total automation of laboratory work flow.
The invention concerns an integrated clinical laboratory computer software system for testing a specimen. One or more specimen processing modules are advantageously provided for performing particular predetermined tests on the specimen. Integrated work flow automation programming communicates with any of the plurality of specimen processing modules. The specimen processing modules can include instrument hardware and embedded process control software.
The work flow automation programming includes 1) request processing programming for processing a user request for any of the tests which are available to be performed by the specimen processing modules, and also includes 2) functional control programming providing functional control of specimen processing modules for performing any of the tests, and which further includes 3) result data management programming which provides processing of test result data of any of the tests. Integrated user interface programming communicates with the integrated work flow automation programming for permitting a user to control and monitor all aspects of the computer system operation, including pre-analytical, analytical and post-analytical tasks.
According to one aspect of the invention, the work flow automation programming further includes programming for allocating and scheduling a set of test requests as between different ones of the specimen processing modules when a plurality of requests for tests have been received and are in need of processing.
According to another aspect of the invention, at least one specimen delivery module is provided for transporting specimens to and from the specimen processing modules and the work flow automation programming further includes programming for controlling specimen position, routing and distribution to processing sites where each of the specimen processing modules perform the tests. The work flow automation programming can further include programming for evaluating compliance of test procedures with quality control requirements.
One important aspect of the invention is that the work flow automation programming is assembled from a plurality of system user objects, each encapsulating a separate user operational category. The plurality of system user objects advantageously include (1) a test operator object for processing user test requests and providing test operation status information for any of the plurality of specimen processing modules and (2) an instrument operator object responsive to user commands for controlling operational modes and status for any of the specimen processing modules.
According to another aspect of the invention, the system user objects can further include one or more objects, such as (3) a service tech object responsive to user commands for performing service tasks relating to maintenance of any the specimen processing modules, (4) a result verifier object responsive to user commands for manual verification of test result data provided by any of the specimen processing modules, and (5) a system administrator object responsive to user requests for managing configuration of the computer system. Finally, the plurality of system user objects can also include a bar code reader user object responsive to user inputs delivered via bar code reading devices. By providing discrete programming objects directed to each user rather than specific functions, the system achieves a level of integration and scaleability which is substantially improved as compared to the prior art.
According to one embodiment of the invention, the work flow automation programming can include programming for maintaining a database of test result data received from of the specimen processing module. Such test result database is preferably accessible by the programming for result data management described above.
The work flow automation programming can advantageously include programming for verifying medical insurance code data provided for a particular test which has been requested. Such programming can be accessed by either the request processing programming or the result data management programming to facilitate billing for testing which has been performed.